FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults

... Within the First Eight Months Since its Introduction in the United St... VYVANSE has Achieved Over One Million PrescriptionsIn a Clini...the Symptoms of ADHD (Inattention Hyperactivity and Impulsivity)(1)...BASINGSTOKE England and PHILADELPHIA April 23 FirstCall/...

Within the First Eight Months Since its Introduction in the United States,

VYVANSE has Achieved Over One Million Prescriptions
In a Clinical Study With Adults, VYVANSE was Shown to Significantly Improve

the Symptoms of ADHD (Inattention, Hyperactivity and Impulsivity)(1)

BASINGSTOKE, England and PHILADELPHIA, April 23 /PRNewswire-FirstCall/
-- Shire plc (LSE: SHP) (NASDAQ: SHPGY,), the global specialty
biopharmaceutical company, today announced that it has received approval
from the U.S. Food and Drug Administration (FDA) for VYVANSE(TM)
(lisdexamfetamine dimesylate), for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in adults. VYVANSE, introduced in July 2007
for the treatment of ADHD in children aged 6 to 12 years, is now the first
and only once-daily prodrug stimulant approved to treat adults with ADHD.
In its first eight months of availability, more than one million VYVANSE
prescriptions have been filled.(2)

"We are very pleased with this FDA approval of the adult indication for
VYVANSE," said Matthew Emmens, Chief Executive Officer of Shire. "This
approval provides physicians a new treatment option that can help their
adult patients by significantly improving their ADHD symptoms. VYVANSE has
been well accepted by the medical community. With Shire's experience as a
leader in the development and commercialization of ADHD medications, we are
confident that this approval for adult patients will help continue to
increase prescription share and volume of VYVANSE."

"Many people may think of ADHD as only a childhood disorder but the
fact is that the majority of children diagnosed with ADHD still have
symptoms as an adult. These symptoms can significantly impact them at work,
home and in relationships, where they have important responsibilities,"
said David W. Goodman, assistant professor of psychiatry and behavioral
sciences at Johns Hopkins University School of Medicine and director of the
Adult Attention Deficit Disorder Center of Maryland. "The good news is that
in a clinical study with adults, one daily dose of VYVANSE significantly
improved ADHD symptoms of inattention, such as the ability to focus and
organize, as well as hyperactivity and impulsivity."

Since VYVANSE became available for children with ADHD in July 2007, the
product has achieved a U.S. market share of 6.9 percent based on weekly
branded prescription volume VYVANSE formulary coverage has been positive,
with the top six managed care plans now covering the product in a preferred
formulary position.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine
is covalently bonded to l-lysine, and after oral ingestion it is converted
to pharmacologically active d-amphetamine.(3) The conversion of VYVANSE to
d-amphetamine is not affected by gastrointestinal pH and is unlikely to be
affected by alterations in normal GI transit times.(4)

VYVANSE is currently available in three dosage strengths of 30 mg, 50
mg and 70 mg, each for once-daily dosing. Additional dosage strengths of 20
mg, 40 mg and 60 mg VYVANSE have also been FDA-approved and are expected to
be available in pharmacies this summer.

Additional information about VYVANSE and Full Prescribing Information
are available at http://www.vyvanse.com.

VYVANSE Significantly Improved ADHD Symptoms

The phase III pivotal trial that led to the FDA approval of VYVANSE to
treat adults with ADHD was a double-blind, placebo-controlled, four-week
study with dose escalations in 414 adults aged 18 to 55 years. In this
study, adults with ADHD experienced significant improvements in ADHD
symptom control within one week of treatment with once-daily VYVANSE.(1)

Treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) was
significantly more effective than placebo, providing a reduction in ADHD
Rating Scale (ADHD-RS-IV) scores ranging from 16.2 to 18.6 points at
endpoint.(1) The ADHD-RS-IV is a standardized test for assessing symptoms
of ADHD and for assessing their response to treatment.(5,6) This scale,
which contains 18 items, is based on the ADHD diagnostic criteria as
defined in the APA's Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition, Text Revision(R), a publication of the American Psychiatric
Association.(7)

Investigators also measured the efficacy of VYVANSE with the Clinical
Global Impressions-Improvement (CGI-I) scale and found that the percentage
of subjects taking VYVANSE that rated improved ranged from 57 to 61 percent
across all doses and was significantly greater than placebo.(1) The CGI-I
scale is a standard assessment used to rate the severity of a patient's
illness and improvement over time.(8)

The most commonly reported adverse events in this study were decreased
appetite, difficulty falling asleep, and dry mouth.

About ADHD

ADHD is one of the most common psychiatric disorders in children and
adolescents.(9) Approximately 7.8 percent of all school-aged children, or
about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed
with ADHD at some point in their lives, according to the U.S. Centers for
Disease Control and Prevention (CDC).(10) The disorder is also estimated to
affect 4.4 percent of U.S. adults aged 18-44 based on results from the
National Comorbidity Survey Replication, a nationally representative
household survey, which used a lay-administered diagnostic interview to
assess a wide range of DSM-IV disorders.(11) ADHD is a neurobiological
disorder that manifests as a persistent pattern of inattention and/or
hyperactivity-impulsivity that is more frequent and severe than is
typically observed in individuals at a comparable level of development.(7)
To be properly diagnosed with ADHD, a child needs to demonstrate at least
six of nine symptoms of inattention; and/or at least six of nine symptoms
of hyperactivity/impulsivity; the onset of which appears before age 7
years; that some impairment from the symptoms is present in two or more
settings (e.g., at school and home); that the symptoms continue for at
least six months; and that there is clinically significant impairment in
social, academic or occupational functioning and the symptoms cannot be
better explained by another psychiatric disorder.(7)

Although there is no "cure" for ADHD, there are accepted treatments
that specifically target its symptoms. The most common standard treatments
include educational approaches, psychological or behavioral modification,
and medication.(12)

Notes to editors

About VYVANSE

Tell the doctor about any heart conditions, including structural
abnormalities, that you, your child, or a family member, may have. Inform
the doctor immediately if you or your child develops symptoms that suggest
heart problems, such as chest pain or fainting.

VYVANSE should not be taken if you or your child has advanced disease
of the blood vessels (arteriosclerosis); symptomatic heart disease;
moderate to severe high blood pressure; overactive thyroid gland
(hyperthyroidism); known allergy or unusual reactions to drugs called
sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma;
a history of problems with alcohol or drugs; agitated states; taken a
monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking VYVANSE if you or your child is being
treated for or has symptoms of depression (sadness, worthlessness, or
hopelessness) or bipolar disorder; has abnormal thought or visions, hears
abnormal sounds, or has been diagnosed with psychosis; has had seizures or
abnormal EEGs; has or has had high blood pressure; exhibits aggressive
behavior or hostility. Tell the doctor immediately if you or your child
develops any of these conditions or symptoms while taking VYVANSE.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events. These events
have also been reported rarely with amphetamine use.

VYVANSE was generally well tolerated in clinical studies. The most
common side effects reported in studies of VYVANSE were: children -
decreased appetite, difficulty falling asleep, stomachache, and
irritability; adult - decreased appetite, difficulty falling asleep, and
dry mouth.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression,
worsening of motion or verbal tics, and Tourette's syndrome have been
associated with use of drugs of this type. Tell the doctor if you or your
child has blurred vision while taking VYVANSE.

Shire PLC

Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention deficit and
hyperactivity disorder (ADHD), human genetic therapies (HGT),
gastrointestinal (GI) and renal diseases. The structure is sufficiently
flexible to allow Shire to target new therapeutic areas to the extent
opportunities arise through acquisitions. Shire's in-licensing, merger and
acquisition efforts are focused on products in niche markets with strong
intellectual property protection either in the US or Europe. Shire believes
that a carefully selected portfolio of products with strategically aligned
and relatively small-scale sales forces will deliver strong results.

Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a
number of risks and uncertainties and are subject to change at any time. In
the event such risks or uncertainties materialize, Shire's results could be
materially affected. The risks and uncertainties include, but are not
limited to, risks associated with: the inherent uncertainty of
pharmaceutical research, product development including, but not limited to
the successful development of JUVISTA(R) (Human TGFb3) and veleglucerase
alfa (GA-GCB); manufacturing and commercialization including, but not
limited to, the establishment in the market of VYVANSE(TM)
(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder
("ADHD")); the impact of competitive products, including, but not limited
to, the impact of those on Shire's ADHD franchise; patents, including but
not limited to, legal challenges relating to Shire's ADHD franchise;
government regulation and approval, including but not limited to the
expected product approval date of INTUNIV(TM) (guanfacine extended release)
(ADHD); Shire's ability to secure new products for commercialization and/or
development; and other risks and uncertainties detailed from time to time
in Shire plc's filings with the Securities and Exchange Commission,
including Shire plc's Annual Report on Form 10-K for the year ended
December 31, 2007.

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